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GSK1120212B · 1 trial · 1 indication
Pharmacokinetic data will include corrected maximum plasma concentration (Cmax) of GSK1120212B. Comparison of Cmax will enable to determine the relative bioavailability of the test formulation with lower DMSO content (Treatment B) and the standard reference formulation (Treatment A). Period 2 PK parameters will be corrected for residual concentrations from Period 1 (based on individual estimates of t1/2) to remove the carry-over effect.
Pharmacokinetic data will include corrected area under the time-concentration curve from time zero (pre-dose) to last time of quantifiable concentration (AUC(0-t)) and AUC from zero to infinity (AUC(0-inf)) of GSK1120212B. Period 2 PK parameters will be corrected for residual concentrations from Period 1 (based on individual estimates of t1/2) to remove the carry-over effect.
Pharmacokinetic data will include corrected time of occurrence of Cmax (tmax) of GSK1120212B. Period 2 PK parameters will be corrected for residual concentrations from Period 1 (based on individual estimates of t1/2) to remove the carry-over effect.
| Arm | Type | Description |
|---|---|---|
| Treatment A: GSK1120212B (Standard DMSO content) | EXPERIMENTAL | Subjects will receive Treatment A in Period 1 or 2 as single oral dose on Day 1 of Period 1 or 2 in fasting condition with water. |
| Treatment B: GSK1120212B (Lower DMSO content) | EXPERIMENTAL | Subjects will receive Treatment B in Period 1 or 2 as single oral dose on Day 1 of Period 1 or 2 in fasting condition with water. |
| Name | Type | Description |
|---|---|---|
| GSK1120212B (Standard DMSO content) | DRUG | Each tablet contains GSK1120212B equivalent to 2 mg of GSK1120212 as drug substance. The coated tablets have a standard DMSO content of theoretical 11.3%. |
| GSK1120212B (Lower DMSO content) | DRUG | Each tablet contains GSK1120212B equivalent to 2 mg of GSK1120212 as drug substance. The coated tablets have a lower DMSO content approximately 9.5%. |
Inclusion Criteria: * Has provided signed, written informed consent. * Male or female, age \>=18 years of age at the time of signing the informed consent form. * Has histologically or cytologically confirmed diagnosis of a solid tumor malignancy that is not responsive to standard therapy (ies) or f...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GE Healthcare Technologies Inc. | GEHC | 1 | PHASE1 | GEH200520/ GEH200521- Part A |
| Zimmer Biomet Holdings, Inc. | ZBH | 1 | - | Undisclosed |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | Olverembatinib |
GSK1120212B is an investigational small molecule being developed for the treatment of cancer. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still being studied for safety and efficacy in patients.
GSK1120212B is being developed by GSK plc, a pharmaceutical company traded on the stock exchange under the ticker symbol GSK. The company is conducting clinical trials to evaluate the drug's safety and effectiveness in treating cancer.
GSK1120212B is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied in a completed Phase 1 trial to assess its bioavailability in patients with solid tumor malignancies.
GSK1120212B has been studied in one completed clinical trial, identified as NCT01725100. This Phase 1 study, titled 'A Study to Determine the Relative Bioavailability of the MEK Inhibitor, Trametinib, in Subjects With Solid Tumor Malignancies,' enrolled 80 participants in the United States.
Yes, GSK1120212B is also known as trametinib. The clinical trial NCT01725100 refers to GSK1120212B as the MEK inhibitor trametinib, indicating that these names refer to the same investigational drug being studied for the treatment of cancer.